FDA Lifts Full Clinical Hold on Rein Therapeutics Phase 2 IPF Trial

The U.S. Food and Drug Administration (FDA) has lifted the full clinical hold on Rein Therapeutics' Phase 2 trial of LTI-03 for idiopathic pulmonary fibrosis (IPF), allowing the company to resume patient enrollment. Rein Therapeutics addressed all FDA concerns, leading to clearance for the global RENEW study to continue, including about 20 U.S. clinical sites and 30 international sites in the UK, Germany, Poland, and Australia. The trial aims to evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 IPF patients. CEO Brian Windsor expressed optimism that LTI-03 could significantly improve IPF treatment by not only slowing fibrosis but also promoting lung repair. Enrollment is expected to restart in late 2025 or early 2026 across multiple U.S. states. This milestone marks a crucial step forward in advancing potential new therapies for a condition with significant unmet medical needs.